Design of the Prevention of Adult Caries Study (PACS): a randomized clinical trial assessing the effect of a chlorhexidine dental coating for the prevention of adult caries

Abstract Background Dental caries is one of the primary causes of tooth loss among adults. It is estimated to affect a majority of Americans aged 55 and older, with a disproportionately higher burden in disadvantaged populations. Although a number of treatments are currently in use for caries prevention in adults, evidence for their efficacy and effectiveness is limited. Methods/Design The Prevention of Adult Caries Study (PACS) is a multicenter, placebo-controlled, double-blind, randomized clinical trial of the efficacy of a chlorhexidine (10% w/v) dental coating in preventing adult caries. Participants (n = 983) were recruited from four different dental delivery systems serving four diverse communities, including one American Indian population, and were randomized to receive either chlorhexidine or a placebo treatment. The primary outcome is the net caries increment (including non-cavitated lesions) from baseline to 13 months of follow-up. A cost-effectiveness analysis also will be considered. Discussion This new dental treatment, if efficacious and approved for use by the Food and Drug Administration (FDA), would become a new in-office, anti-microbial agent for the prevention of adult caries in the United States. Trial Registration Number NCT0035787

Results from the Xylitol for Adult Caries Trial (X-ACT)

Although caries is prevalent in adults, few preventive therapies have been tested in adult populations. This randomized clinical trial evaluated the effectiveness of xylitol lozenges in preventing caries in elevated caries-risk adults

Design of the Prevention of Adult Caries Study (PACS): A randomized clinical trial assessing the effect of a chlorhexidine dental coating for the prevention of adult caries

<p>Abstract</p> <p>Background</p> <p>Dental caries is one of the primary causes of tooth loss among adults. It is estimated to affect a majority of Americans aged 55 and older, with a disproportionately higher burden in disadvantaged populations. Although a number of treatments are currently in use for caries prevention in adults, evidence for their efficacy and effectiveness is limited.</p> <p>Methods/Design</p> <p>The Prevention of Adult Caries Study (PACS) is a multicenter, placebo-controlled, double-blind, randomized clinical trial of the efficacy of a chlorhexidine (10% w/v) dental coating in preventing adult caries. Participants (n = 983) were recruited from four different dental delivery systems serving four diverse communities, including one American Indian population, and were randomized to receive either chlorhexidine or a placebo treatment. The primary outcome is the net caries increment (including non-cavitated lesions) from baseline to 13 months of follow-up. A cost-effectiveness analysis also will be considered.</p> <p>Discussion</p> <p>This new dental treatment, if efficacious and approved for use by the Food and Drug Administration (FDA), would become a new in-office, anti-microbial agent for the prevention of adult caries in the United States.</p> <p>Trial Registration Number</p> <p>NCT00357877</p

Technical and Data Collection Challenges and Lessons Learned in the Pain Program for Active Coping and Training (PPACT) Pragmatic Trial

Background/Aims: Chronic pain affects at least 116 million adults in the United States and exacts a tremendous cost in suffering and lost productivity. While health systems offer specialized pain services, the primary care setting is where most patients seek and receive care for pain. The Pain Program for Active Coping and Training (PPACT) project is testing the effectiveness of integrating an evidence-based, interdisciplinary pain management intervention within a primary care environment. Methods: The Kaiser Permanente Northwest (KPNW), Georgia (KPGA) and Hawaii (KPHI) regions are working with their regional health partners to recruit and implement the PPACT trial. Efforts at each clinical site involve extracting electronic medical record data via the virtual data warehouse and Clarity. KPNW built a tracking system to manage all the recruitment and implementation processes across the three regions. The tracking system serves to: 1) house records of study eligible patients; 2) manage touches with the PCPs prior to recruitment to ensure we recruit patients whom PCPs specifically believe this program would work best; 3) keep track of the recruitment efforts; 4) track all intervention activities; and 5) aide in data collection processes using KP.org questionnaires and Kaiser Permanente Message Center IVR surveys. Results: We have implemented recruitment efforts across all regions using a staggered cohort approach. KPNW started cohort 1 as a pilot to firm up all tracking, recruitment and intervention processes. Both KPGA and KPHI are now in the field as well. We are continuing to refine our processes to meet the recruitment challenges we have encountered in the regions. Discussion: Running a pragmatic trial embedded within a health care system is challenging but possible. Adequate collaboration with regional leaders, clinical managers and PCPs to learn the needs of patients and meet expectations for a complex trial is crucial, as is sufficient time to set up data collection processes within the health care setting and test research tracking systems and processes necessary to make operations run as smooth as possible. This presentation will highlight the technical and data collection challenges and lessons learned for conducting a pragmatic trial in a health care setting